Z-0448-2022 Class II Terminated
FDA device recall Z-0448-2022 was initiated by Flower Orthopedics Corporation on November 2, 2021 and is designated Class II. Reason for recall: Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a s… The recall status is terminated (terminated October 12, 2023). Affected quantity: 48 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 12, 2022
- Initiation Date
- November 2, 2021
- Termination Date
- October 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 units
Product Description
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
Reason for Recall
Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.
Code Information
Lot Number: 11090 UDI: 00840118117548